S1 Transforaminal Injection and Vascular Incidence

• Sponsor: Keimyung University Dongsan Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04634955
• Collaborator: (none)
• Enrollment: 97
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9.5
• Patients Per Site Per Month: 10.3

Study Details

Study Description

Brief Summary

Intravascular incidence during S1 transforaminal injection is known to be higher than lumbar injection. Its incidence is reported to be 15~25%.

This study was aimed to see if there is any benefit of reducing the intravasuclar injection rate when S1 transforaminal injection was performed by different fluorosopic approach.

Condition or Disease	Intervention/Treatment	Phase
Inadvertent Arterial Puncture	Procedure: tranforaminal epidural injection	N/A

Detailed Description

Fluorosocpically guided transforaminal epidural steroid injection is a popular interventional procedure that is effective in radicular pain conditions such as herniated interverebral disc, spinal stenosis and failed back surgery syndrome.

The incidence of inadvertent intravascular needle injection during lumbar transforaminal injection is reported as from 9.9% to 30.8%. In particular, S1 intravascular injection rate is more frequent than at the lumbar level.

Previous study reported that guiding the needle toward the S1 foramen using the S1 scotty dog image as a bony landmark, not in the classic way, but in an oblique fluoroscopic view, during L5 and S1 transforaminal epidural steroid injection, can save procedure time and reduce the risk of radiation exposure.

In this stidy, the investigators aimed to compare the incidence of intravascular injection rate by anteroposterior and oblique view approaches for S1 transforaminal epidural steroid injection. In addition, the investigators also compared the procedure time and radiation exposure between two approach method.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Intravascular Incidence With Different Fluoroscopic Approach Method During S1 Trasnforaminal Injection
• Actual Study Start Date: Aug 15, 2020
• Anticipated Primary Completion Date: May 15, 2021
• Anticipated Study Completion Date: May 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: S1 transforaminal injection with oboique view S1 transforaminal injection with oblique fluoroscopic view	Procedure: tranforaminal epidural injection; tranforaminal epidural injection which is performed by fluoroscopic guidance
Active Comparator: S1 transforaminal injection with AP view S1 transforaminal injection with anteroposterior fluoroscopic view	Procedure: tranforaminal epidural injection; tranforaminal epidural injection which is performed by fluoroscopic guidance

Outcome Measures

Primary Outcome Measures

1. intravascular incidence [15 minutes after the completion of the intervention]

   intravascular injection rate

Secondary Outcome Measures

1. procedure time [15 minutes after the completion of the intervention]

   procedure time

2. radiation dose [15 minutes after the completion of the intervention]

   radiation dose

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• spinal stenosis

• herniated intervertebral disc

• failed back surgery syndrome

Exclusion Criteria:

• coagulopathy

• infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hong ji HEE	Daegu		Korea, Republic of	42601

Sponsors and Collaborators

• Keimyung University Dongsan Medical Center

Investigators

• Principal Investigator: Ji Hee Hong, PhD, Keimyung University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ji Hee Hong, Principal Investigator, Keimyung University Dongsan Medical Center
• ClinicalTrials.gov Identifier: NCT04634955
• Other Study ID Numbers: 2020-08-028
• First Posted: Nov 18, 2020
• Last Update Posted: Dec 29, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ji Hee Hong, Principal Investigator, Keimyung University Dongsan Medical Center: intravascular injection transforaminal injection

Study Results

No Results Posted as of Dec 29, 2020